Handlers of imported food and supplement products have until Dec. 12 to register their facilities with the U.S. Food and Drug Administration, under the terms of the Bioterrorism Act of 2002.
The FDA published interim final rules Oct. 9 for two parts of the Bioterrorism Act. One section requires most food facilities in the United States to register with the FDA and foreign entities doing business here to appoint a domestic agent. The other section changes the rules covering prior notice to the FDA of food shipments arriving on U.S. soil.
The registration rule applies to domestic or foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States. It defines "food" to include dietary supplements and dietary ingredients, infant formula, beverages (including alcohol and bottled water), fruits and vegetables, fish and seafood, dairy products and shell eggs, raw agricultural commodities for use as food, canned and frozen food, bakery goods, snack food and candy, live food animals, animal feeds and pet food.
Retailers are not required to register. Neither are private homes, municipal water systems, transport carriers, farms, restaurants, nonprofit food establishments such as food banks and soup kitchens, fishing vessels or meat-packing plants that are regulated by the U.S. Department of Agriculture.
The prior-notice rule requires importers or brokers to notify the FDA two to eight hours before a foreign food shipment arrives, depending on the mode of transportation. It adds food regulators to a prior-notice list that already includes the U.S. Bureau of Customs and Border Protection.
Regulators scaled back some of the proposed rules in an effort to make them less burdensome to the food industry, and the FDA said it will use "enforcement discretion" for the first four months. FDA will provide a 75-day comment period on issues related to the rule's implementation. For information about how to comment, see www.fda.gov/oc/bioterrorism/bioact.html. Interim final rules about other sections of the Bioterrorism Act are forthcoming.
Specifics about both elements of the rule, including deadlines and phone numbers, are posted on the FDA's Center for Food Safety and Applied Nutrition Web site, www.cfsan.fda.gov. For paper copies, call the FDA in Rockville, Md., at 877.332.3882.
Natural Foods Merchandiser volume XXIV/number 11/p. 9